Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Patients With Advanced Solid Tumors
The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.
The drug being tested in this study is MLN4924. MLN4924 is being evaluated to assess
drug-drug interactions (DDIs) with the moderate and strong CYP3A inhibitors, fluconazole and
itraconazole, respectively, in participants with advanced solid tumors. This study will look
at the blood concentrations of MLN4924 as it relates to treatment with fluconazole and
itraconazole.
The study will enroll approximately 52 participants. In Part A, participants will be
administered MLN4924 via a 1-hour (+- 5 minutes) intravenous (IV) infusion in combination
with either fluconazole or itraconazole administered orally. After participants complete Part
A, they will have the opportunity to begin treatment in Part B. In Part B, participants will
be administered MLN4924 via a 1-hour (+- 5 minutes) IV infusion in combination with either
docetaxel or carboplatin + paclitaxel, the three of which would also be administered
intravenously.
This multi-center trial will be conducted in the United States. Participation in Part A of
this study will include a screening visit and two weeks of treatment; participation in Part B
of this study will include up to an 8-week drug washout period (from last dosing in Part A)
and treatment until participants experience symptomatic deterioration, progressive disease,
until treatment is discontinued for another reason, or until the study is stopped.
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